EP3030245A1 - Improvement of blood lipids, glucose tolerance and insulin sensitivity - Google Patents
Improvement of blood lipids, glucose tolerance and insulin sensitivityInfo
- Publication number
- EP3030245A1 EP3030245A1 EP14833801.5A EP14833801A EP3030245A1 EP 3030245 A1 EP3030245 A1 EP 3030245A1 EP 14833801 A EP14833801 A EP 14833801A EP 3030245 A1 EP3030245 A1 EP 3030245A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- individual
- resistant
- potato starch
- starch
- treatment
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/718—Starch or degraded starch, e.g. amylose, amylopectin
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
- A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
- A23L29/212—Starch; Modified starch; Starch derivatives, e.g. esters or ethers
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
- A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
- A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- Resistant starch is defined as the sum of starch and starch digestion products that are not digested in the small intestine but instead reach the large intestine as a fermentable fiber substrate.
- Previous research has established RS as an effective dietary prebiotic supplement to modulate intestinal function and improve systemic health in both animals and humans.
- RS has potential application in weight management, the treatment of gastrointestinal disorders, and the improvement of blood lipids, glucose tolerance and insulin sensitivity [1 , 2].
- a method of increasing High Density Lipoprotein plasma levels in an individual in need of such treatment comprising administering to said individual an effective amount of resistant potato starch.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- resistant potato starch to increase High Density Lipoprotein plasma levels in an individual in need of such treatment.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- resistant potato starch in the preparation of a medicament for increasing High Density Lipoprotein plasma levels in an individual in need of such treatment.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- an individual in need of such treatment may be an individual with a fasting HDL plasma level below 40 mg/dL or below 1 mmol/L or an individual with a fasting LDL to HDL ratio of greater than 5 or an individual with high fasting LDL levels combined with low fasting HDL levels or an individual with a familial history of cardiovascular disease or who is otherwise considered to be at risk of developing cardiovascular disease.
- a method of decreasing blood glucose levels in an individual in need of such treatment comprising administering to said individual an effective amount of resistant potato starch.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- resistant potato starch to decrease blood glucose levels in an individual in need of such treatment.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- resistant potato starch in the preparation of a medicament for decreasing blood glucose levels in an individual in need of such treatment.
- the resistant potato starch is SPrebiotic® Resistant Potato Starch.
- an individual in need of such treatment in these embodiments may be for example an individual who has or is at risk of having a blood glucose level outside the normal range, that is, greater than between 70 and 100 mg/dL, or greater than 100 mg/dL
- the individual may be an individual who has diabetes and who has or is suspected of having or is at risk of having a blood glucose range for outside of 70-130 mg/dL or greater than 130 mg/dL before meals and less than 180 mg/dL after meals.
- the individual in need of such treatment may be hyperglycemic or chronically hyperglycemic or may be diabetic.
- the individual is a human.
- a method of decreasing insulin resistance in an individual in need of such treatment comprising administering to said individual an effective amount of resistant potato starch.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- resistant potato starch to decrease insulin resistance in an individual in need of such treatment.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- resistant potato starch in the preparation of a medicament for decreasing insulin resistance in an individual in need of such treatment.
- the resistant potato starch is MSPrebiotic® Resistant Starch.
- an individual in need of such treatment may be an individual with increased insulin resistance, for example an individual with Type 2 diabetes or a person with a familial history of Type 2 diabetes or a person at risk of developing Type 2 diabetes.
- Figure 1 Time course of body weight gain (lbs).
- Figure 2 Blood Lipid Response (mmol/L).
- Figure 3 HDL Particle Number ( ⁇ /L).
- MSP Starch Products Inc. manufactures MSPrebiotic® Resistant Potato Starch, a native, unmodified RS type 2 preparation of food grade quality for animal and human food application.
- MSPrebiotic® Resistant Potato Starch As a novel health promoting fiber vehicle in the human nutraceutical industry, a pre-clinical examination of the metabolic health benefits of a novel MSPrebiotic® Resistant Potato Starch capsule in a domestic pig model fed a typical Western diet was undertaken.
- Resistant Potato Starch supplementation increased (p ⁇ 0.05) plasma total HDL- particles (28%) and reduced blood glucose (-11%) and insulin resistance (- 54%) as estimated by HOMA-IR.
- High-Density Lipoprotein is one of the five major groups of lipoproteins. Specifically, HDL is the smallest of the lipoprotein particles and transports cholesterol primarily to the liver. Furthermore, increasing one's HDL levels has been found to improve cardiovascular health. Specifically, individuals with low HDL-C levels, for example, lower than 40 mg/dL or about 1 mmol/L or individuals who have a ratio of LDL-C (Low Density Lipoprotein) to HDL-C of 5 or greater are considered to be at greater risk of developing cardiovascular diseases.
- LDL-C Low Density Lipoprotein
- MSPrebioitc® Resistant Potato Starch has been shown to increase the total number of HDL-particles in plasma compared to a control of similar age and fed an otherwise substantially similar diet by 28%.
- an effective amount of resistant potato starch for example, MSPrebiotic® Resistant Potato Starch
- an individual is a human.
- a method of increasing High Density Lipoprotein plasma levels in an individual in need of such treatment comprising administering to said individual an effective amount of resistant potato starch.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- the increase in HDL particle number or HDL plasma level in the individual may be in comparison to the HDL particle number or HDL plasma level in said individual prior to beginning
- the increase may be in comparison to an untreated control of similar age and condition.
- the control does not necessarily need to be repeated every time.
- the effective amount may vary according to many different factors, for example, the age, weight, and/or condition of the individual. It is of note that the appropriate effective amount for a given individual can be easily determined through routine experimentation.
- an "effective amount" particularly for humans, may be 0.25 grams to 40 grams of MSPrebioitc® Resistant Potato Starch. Alternatively, an effective amount may be 0.5 grams to 40 grams or 0.25 grams to 30 grams or 0.5 grams to 30 grams.
- the "effective amount" may be taken on a regular schedule or regimen, for example, once per day or every other day.
- the "effective amount” does not need to be taken in a single dose and may be taken in multiple or partial doses throughout the day, as discussed herein.
- resistant starch examples include but are by no means limited to for example 250 mg capsules or tablets, 500 mg capsules or tablets, a teaspoon of resistant starch, a tablespoon of resistant starch and the like.
- a "teaspoon" is typically considered to correspond to approximately 5 grams while a tablespoon is considered to correspond to
- the resistant starch may be in the form of a powder.
- Other suitable dosages will be readily apparent to one of skill in the art.
- the "effective amount” may be for example one or more teaspoon(s) of MSPrebioitc® Resistant Potato Starch, for example, one, two, three or four teaspoon(s) MSPrebioitc® Resistant Potato Starch.
- this dosage may be taken on a regular schedule or regime, for example, once per day, twice per day, three times per day, four times per day, every other day or as needed or desired.
- the "effective amount" may be for example one or more tablespoon(s) of MSPrebioitc® Resistant Potato Starch, for example, one, two or three tablespoon(s) MSPrebioitc® Resistant Potato Starch.
- this dosage may be taken on a regular schedule or regime, for example, once per day, twice per day, three times per day, four times per day, every other day or as needed or desired.
- resistant starch may be used within the invention, provided the product or medicament comprising the resistant starch, for example resistant potato starch, for example MSPrebiotic® Resistant Potato Starch, is high in resistant starch.
- a starch that has "high" resistant starch content is a starch that is at least 60% resistant starch.
- the resistant potato starch used in the embodiments of the invention is at least 60% resistant potato starch.
- the inventors have discovered that a key aspect in maintaining the integrity of the resistant starch, that is maintain the starch as a high resistant starch is maintaining the starch at a temperature below 60C. As will be apparent to one of skill in the art, this includes production of the resistant starch itself and also preparation of medicaments such as tablets and capsules and functional foods and/or beverages to which the resistant starch is added.
- resistant potato starch to increase High Density Lipoprotein plasma levels in an individual in need of such treatment.
- the resistant potato starch is MSPrebiotic® Resistant Starch.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- MSPrebiotic® Resistant Potato Starch in the preparation of a medicament for increasing High Density Lipoprotein plasma levels in an individual in need of such treatment.
- MSPrebiotic® Resistant Potato Starch in the preparation of a medicament for reducing the risk of cardiovascular disease in an individual in need of such treatment.
- an individual in need of such treatment may be an individual with a fasting HDL plasma level below 40 mg/dL or below 1 mmol/L or an individual with a fasting LDL to HDL ratio of greater than 5 or an individual with high fasting LDL levels combined with low fasting HDL levels or an individual with a familial history of cardiovascular disease or who is otherwise considered to be at risk of developing cardiovascular disease.
- the individual is a human.
- the blood sugar concentration or blood glucose level is the amount of glucose present in blood.
- the mean normal level in humans is about 5.5 m (5.5 mmol/L or 100 mg/dL).
- the normal blood glucose level for non-diabetics should be between 70 and 100 mg/dL.
- the blood glucose target range for diabetics should be 70-130 mg/dL before meals and less than 180 mg/dL after eating. Blood sugar levels that are persistently high are referred to as hyperglycemic and diabetes is characterized by persistent hyperglycemia.
- the treatment group fed MSPrebiotic® Resistant Potato Starch demonstrated reduced blood glucose (-11 %) compared to a control of similar age and fed an otherwise substantially similar diet.
- an effective amount of resistant potato starch for example, MSPrebiotic® Resistant Potato Starch can be administered to an individual in need of such treatment to decrease blood glucose.
- a method of decreasing blood glucose levels in an individual in need of such treatment comprising administering to said individual an effective amount of resistant potato starch.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- the decrease in blood glucose levels in the individual may be in comparison to the glucose levels in said individual prior to beginning administration or treatment. Alternatively, the decrease may be in comparison to an untreated control of similar age and condition. As will be appreciated by one of skill in the art, the decrease in blood glucose levels in the individual may be in comparison to the glucose levels in said individual prior to beginning administration or treatment. Alternatively, the decrease may be in comparison to an untreated control of similar age and condition. As will be appreciated by one of skill in the art, the decrease may be in comparison to the glucose levels in said individual prior to beginning administration or treatment. Alternatively, the decrease may be in comparison to an untreated control of similar age and condition. As will be appreciated by one of skill in the art, the decrease may be in comparison to an untreated control of similar age and condition.
- control does not necessarily need to be repeated every time.
- the effective amount may vary according to many different factors, for example, the age, weight, and/or condition of the individual. It is of note that the appropriate effective amount for a given individual can be easily determined through routine experimentation.
- resistant potato starch for example, MSPrebiotic® Resistant Potato Starch
- MSPrebiotic® Resistant Potato Starch to decrease blood glucose levels in an individual in need of such treatment.
- resistant potato starch in the preparation of a medicament for decreasing blood glucose levels in an individual in need of such treatment.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- MSPrebiotic® Resistant Potato Starch in the preparation of a medicament for decreasing blood glucose levels in an individual in need of such treatment.
- MSPrebiotic® Resistant Potato Starch in the preparation of a medicament for treating diabetes in an individual in need of such treatment.
- an individual in need of such treatment may be for example an individual who has or is at risk of having a blood glucose level outside the normal range, that is, greater than between 70 and 100 mg/dL, or greater than 100 mg/dL.
- the individual may be an individual who has diabetes and who has or is suspected of having or is at risk of having a blood glucose range for outside of 70-130 mg/dL or greater than 130 mg/dL before meals and less than 180 mg/dL after meals.
- the individual in need of such treatment may be hyperglycemic or chronically hyperglycemic or may be diabetic.
- the individual is a human.
- Insulin resistance is a physiological condition in which cells fail to respond to the normal actions of insulin. Specifically, as a result of changes in their surface receptors, cells are unable to use insulin as effectively and beta cells in the pancreas increase their production of insulin which in turn leads to hyperglycemia. Insulin resistance is generally associated with Type 2 diabetes.
- the treatment group fed MSPrebiotic® Resistant Potato Starch demonstrated a reduction in insulin resistance of 54% as estimated by HOMA- IR compared to the control group.
- an effective amount of resistant potato starch for example, MSPrebiotic® Resistant Potato Starch can be administered to an individual in need of such treatment to decrease insulin resistance.
- a method of decreasing insulin resistance in an individual in need of such treatment comprising administering to said individual an effective amount of resistant potato starch.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- the decrease in insulin resistance in the individual may be in comparison to insulin resistance in said individual prior to beginning administration or treatment.
- the decrease may be in comparison to an untreated control of similar age and condition.
- the control does not necessarily need to be repeated every time.
- the effective amount may vary according to many different factors, for example, the age, weight, and/or condition of the individual. It is of note that the appropriate effective amount for a given individual can be easily determined through routine experimentation.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- resistant potato starch in the preparation of a medicament for decreasing insulin resistance in an individual in need of such treatment.
- the resistant potato starch is MSPrebiotic® Resistant Potato Starch.
- MSPrebiotic® Resistant Potato Starch in the preparation of a medicament for treating type 2 diabetes in an individual in need of such treatment.
- an individual in need of such treatment may be an individual with increased insulin resistance, for example an individual with Type 2 diabetes or a person with a familial history of Type 2 diabetes or a person at risk of developing Type 2 diabetes.
- resistant potato starch for example, MSPrebiotic® Resistant Potato Starch is an effective dietary supplement offering protection against multiple metabolic risk factors that are associated with cardiovascular disease and diabetes.
- a method of increasing High Density Lipoprotein plasma levels in an individual in need of such treatment comprising administering to said individual 0.25 grams to 40 grams of MSPrebiotic® Resistant Potato Starch daily.
- an individual in need of such treatment may be an individual with a fasting HDL plasma level below 40 mg/dL or below 1 mmol/L or an individual with a fasting LDL to HDL ratio of greater than 5 or an individual with high fasting LDL levels combined with low fasting HDL levels or an individual with a familial history of cardiovascular disease or who is otherwise considered to be at risk of developing cardiovascular disease.
- a method of decreasing blood glucose levels in an individual in need of such treatment comprising administering to said individual 0.25 grams to 40 grams of MSPrebiotic® Resistant Potato Starch daily.
- an individual in need of such treatment in these embodiments may be for example an individual who has or is at risk of having a blood glucose level outside the normal range, that is, greater than between 70 and 100 mg/dL, or greater than 100 mg/dL.
- the individual may be an individual who has diabetes and who has or is suspected of having or is at risk of having a blood glucose range for outside of 70- 30 mg/dL or greater than 130 mg/dL before meals and less than 180 mg/dL after meals.
- the individual in need of such treatment may be hyperglycemic or chronically hyperglycemic or may be diabetic.
- the individual is a human.
- a method of decreasing insulin resistance in an individual in need of such treatment comprising administering to said individual 0.25 grams to 40 grams of MSPrebiotic® Resistant Potato Starch daily.
- an individual in need of such treatment may be an individual with increased insulin resistance, for example an individual with Type 2 diabetes or a person with a familial history of Type 2 diabetes or a person at risk of developing Type 2 diabetes.
- “daily” does not necessarily mean “every day” but may mean 70%, 80%, 90% or more of days within a given month or other suitable time period.
- MSPrebiotic® Resistant Potato Starch can be developed and are within the scope of the invention, for example, a capsule in the nutraceutical industry as well as alternative food and/or beverage options that would more readily allow daily RS intakes in an effective amount, for example, as discussed herein.
- the lipoprotein can be referred to as the 'boat' while the HDL-C itself is the 'cargo'.
- the pre-c!inical assessment included the following metabolic parameters in response to dietary supplementation of MSPrebiotic® Resistant Starch capsules for 30 days:
- Standard fasting assessment of lipid biomarkers of cardiovascular disease risk including blood total cholesterol, low-density lipoprotein (LDL) cholesterol, high- density lipoprotein (HDL) cholesterol, and triglycerides (TAG).
- LDL low-density lipoprotein
- HDL high- density lipoprotein
- TAG triglycerides
- VLDL very low- density lipoprotein
- LDL low- density lipoprotein
- HDL particle number and size HDL particle number and size
- MSPrebiotic® Resistant Potato Starch is an effective cardioprotective supplement to reduce cardiovascular disease risk by elevating the number of HDL lipoprotein particles.
- results of this pre-clinical evaluation indicate that dietary supplementation of MSPrebiotic® Resistant Potato Starch capsules at a controlled dose of for example 10 g/d is an effective strategy to favorably modulate multiple markers of metabolic syndrome including blood glucose and insulin, as well as HDL particle number.
- each animal received -31 capsules/d mixed in with the morning and evening meals to reach a target RS intake of 10 g/d.
- Composition of the gelatinized and MSPrebiotic® Resistant Potato Starch is presented in Table 2.
- each pig was weighed and a fasting blood sample (-5 mis) was obtained from the ear vein into sodium heparin tubes while the pigs were sedated with an intramuscular injection of a swine premix solution [Telazol (100mg/ml) at 4.4-6mg/kg and xylazine (100mg/ml) at 2.2mg/kg].
- a swine premix solution [Telazol (100mg/ml) at 4.4-6mg/kg and xylazine (100mg/ml) at 2.2mg/kg].
- This blood sample was used as a baseline for all endpoint blood measures.
- the pigs were fed their respective test diets at a level of roughly 5.5 % of their body weight for the duration of the experiment. Feed intake was monitored on a daily basis while body weights were taken at weekly intervals. On d-30 of the experimental period following an 8-hour overnight fast, the pigs were weighed, sedated with an
- Plasma total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and TAG were determined by automated enzymatic kits on a Pentra 400 autoanalyzer (Kamiya Biomedical Company, Seattle, WA, USA). Direct assessment of lipoprotein particle number and size was conducted by nuclear magnetic resonance spectroscopy (Liposcience, Raleigh, NC). Serum insulin was analysed by ELISA (EZRMI-13K, Millipore, Billerica, MA) and glucose was measured by colorimetric analysis (ab6533, abeam, Cambridge, MA). Insulin resistance was estimated by homeostatic model assessment (HOMA-IR). Blood C- reactive protein (CRP) as measured by ELISA (10011236, Cayman Chemical).
- the inventors attempted to develop resistant starch-containing capsules. However, initial attempts were unsuccessful as the resistant starch tended to clump together and was difficult to fill or flow into a suitably sized capsule. It was subsequently discovered that carefully drying the resistant starch to a moisture content of below 20% for example between 12-19% produced flowable starch that did not stick together. In other embodiments, the moisture content may be beiow 17%, for example, 12-17% or 12-15%.
- a method of preparing a resistant starch capsule comprising drying a quantity of resistant starch to below 20%, for example, below 17% and then flowing the dried resistant starch into a capsule.
- the moisture content may be 12-19%, 12-17% or 12-15%.
- the inventors also attempted to prepare resistant starch tablets as there were concerns that the resistant starch capsules may not have been the ideal delivery mechanism due to slow release of the resistant starch from the capsule.
- solution of a suitable excipient is prepared and resistant starch is added to the solution.
- the mixture is then allowed to form into pellets or granules.
- the granules are dried and then reduced in size using any suitable means known in the art.
- the resistant starch material is formed into a tablet under a suitable pressure.
- pressures typically used for tablet preparation for example 200 - 500 MPa in the preparation of such tablets fractured the granule structure of the resistant starch, thereby greatly reducing the quantity of resistant starch in the tablet.
- Subsequent experimentation showed that pressures between 60 - 100 MPa is suitable to produce the tablet, while lower pressures produced tablets which broke apart and higher pressures fractured the granule structure of the resistant starch to an unacceptable degree.
- the excipient is a binder, for example,
- PVP polyvinylpyrrolidone
- the pharmaceutical composition is prepared as follows: an aqueous solution of 1 part PVP is prepared. 9 parts resistant starch is dissolved therein at a temperature below 60°C. Pellets and granules are allowed to form which are then dried. The dried material is reduced in size with a hammer mill. The material is then formed into a tablet and subjected to a pressure between for example 45-100 MPa or in some preferred embodiments between 60-100 MPa.
- the capsules and tablets may be made in any suitable size, for example, in a unit dosage to be taken once per day, or in dosages to be taken multiple times per day, for example twice or more per day on a suitable dosage regimen or schedule.
- a suitable dosage regimen may be one or more capsules or tablets comprising 50-750 mg resistant starch prepared as discussed herein every 2, 4, 6, 8, 12 or 24 hours or taken with meals.
- the capsules or tablets may be 50 mg, 100 mg, 200 mg, 220 mg, 250 mg, 300 mg, 350 mg, 400 mg, 450 mg, 500 mg, 600 mg, 700 mg, 750 mg or any suitable similar size according to patient and/or consumer preference.
- each capsule may weigh 625 ⁇ 5.0 mg and each capsule may contain 528 ⁇ 17.6 mg of material of which 350-370 mg is resistant starch.
- the material is formed into tablets at a pressure between 45-100 MPa or between 60-100 MPa.
- each tablet is 40-50% resistant starch, for example, 45% resistant starch.
- a method of preparing a resistant starch pharmaceutical composition comprising mixing an effective amount of resistant starch with a suitable excipient.
- the excipient may be PVP.
- the mixture may be 1 part PVP to 9 parts resistant starch or resistant starch source.
- the pharmaceutical composition is in the form of a tablet.
- resistant starch is dried to a moisture content below 20% for example between 12- 9% or below 17% for example between 12-17% and flowed into a suitably sized capsule, thereby producing a resistant starch capsule.
- an effective amount will depend on the animal, its age, weight and general condition, among other factors. However, as discussed above, the inventors have discovered that a much lower level of resistant starch than previously believed is sufficient to treat or otherwise
- the "effective amount" is resistant starch at approximately 0.1%-2.5%, 0.1-2.0%, 0.1- 1.5%, 0.1-1.0%, 0.2-2.5%, 0.2-2.0%, 0.2-1.5%, 0.2-1.0%, 0.3-2.5%. 0.3-2.0%, 0.3- 1.5%, 0.3-1.0%, 0.4-2.5%. 0.4-2.0%, 0.4-1.5%, 0.4-1.0%, 0.5-2.5%. 0.5-2.0%, 0.5- 1.5%, or 0.5-1.0% of the animal's diet.
- the "effective amount" may be a resistant starch capsule or tablet.
- the resistant starch capsule or tablet may be prepared according to the methods described herein.
- the resistant starch capsule is a 500 mg capsule.
- the tablet may be a 220 mg tablet or a 250 mg tablet.
- Formulation: 90 % resistant starch + 10 % PVP, the water should be 30% of the total amount of the flour. For example, 9 kg resistant starch plus 1 kg PVP, the water should be 10 30% 3kg (3 liter).
- Step 1 Resistant starch, PVP, and water are weighed respectively.
- Step 2 Dissolve the PVP into water, heat and dissolve it.
- Step 3 Cool down the PVP solution in ice water bath into room temperature.
- Step 4 Add the PVP solution, into Resistant starch powders and mix thoroughly with a mixer (10 - 20 min depending on the amount).
- Step 5 Screening the damp mass through a mesh to form pellets or granules with a granulator.
- Step 6 Drying the granules by using a dryer in 40-45 °C for about 72h, depending on the amount of the granules prepared.
- Step 7 After the granules are dried, they are passed through a hammer mill (We use #4 screen, with 0.75mm diameter holes).
- Step 8 Go through the tablet machine (Pressure of 60 - 100 MPa is required for the resistant starch which contains 60 - 75% RS. Higher RS requires higher pressure.
- the final tablet product should contain about 40% RS, db).
- Resistant starch (%) 0 60
- Resistant starch 0 0.32
- Robertson MD Dietary-resistant starch and glucose metabolism. Curr Opin Clin Nutr Metab Care 2012, 15(4):362-367.
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Abstract
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US201361863004P | 2013-08-07 | 2013-08-07 | |
PCT/CA2014/050740 WO2015017934A1 (en) | 2013-08-07 | 2014-08-07 | Improvement of blood lipids, glucose tolerance and insulin sensitivity |
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